NCT05767359

CAR- PRISM (PRecision Intervention Smoldering Myeloma)

CAR- PRISM (PRecision Intervention Smoldering Myeloma): A Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in High-Risk Smoldering Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: * Cilta-cel (or chimeric antigen receptor T cells) * Cyclophosphamide (a lymphodepleting chemotherapy) * Fludarabine (a lymphodepleting chemotherapy)

Detailed description

This is a Phase II study to test the safety and effectiveness of study therapy cilta-cel in treating participants with high-risk smoldering multiple myeloma (SMM). T cells are a part of a person's immune system which usually helps fight infection and prevents/fights cancer cells. The U.S. Food and Drug Administration (FDA) has approved cilta-cel as a treatment for relapsed and refractory multiple myeloma but not specifically for smoldering myeloma. The research study procedures include screening for eligibility, study treatment including evaluations, blood collections, radiologic scans of tumors, bone marrow biopsies, and follow-up visits. Participation in this study is expected to last about 15 years. It is expected that about 20 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational therapy to learn whether the therapy works in treating a specific disease. "Investigational" means that the therapy is being studied. Janssen Research \& Development, LLC is supporting this research study by providing the study treatment and funding.

Conditions

• Multiple Myeloma
• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ciltacabtagene Autoleucel	Genetically modified autologous T-cell immunotherapy, via intravenous infusion per protocol.
DRUG	Cyclophosphamide	Lymphodepleting conditioning regimen, nitrogen mustard-derivative, via intravenous infusion per standard care.
DRUG	Fludarabine Phosphate	Lymphodepleting conditioning regimen, synthetic purine nucleoside, via intravenous infusion per standard care.

Timeline

• Start date: 2023-04-19
• Primary completion: 2025-12-15
• Completion: 2040-01-15
• First posted: 2023-03-14
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study